FDA halts TACT chelation study
Archive of TACT study web site - This is an archive of the "portal" site for the NIH-sponsored Trial to Assess Chelation Therapy (TACT). OmniComm Systems administered the site, which, for most of its existence, was password-protected so that only investigators and others connected with TACT could access it. In May 2008, the password protection was removed, possibly in error, which enabled critics of the trial to explore more than 150 related documents. Not long afterward, the site was completely removed.
Pennsylvania Parents sue doctor and labs after son died after chelation therapy for autism.
The parents of a 5-year-old autistic child who was killed by chelation therapy are suing Roy Kerry, M.D., ApothéCure (a compounding pharmacy), and several other associated individuals and companies. The suit seeks punitive damages as well as damages for wrongful death and lack of informed consent. Kerry is also facing disciplinary action by the Pennsylvania Board of Medicine.
Robban Sica, M.D. charged again
Stephen Barrett, M.D. - Quackwatch
Robban A. Sica, M.D., who operates the Center for the Healing Arts in Orange, Connecticut. is facing disciplinary action for questionable management of about 40 patients. She is charged with improperly using chelation therapy to treat cardiovascular disease, failing to obtain adequate consent for such treatment, and failing to properly manage many of these patients whom she said were suffering from heavy metal toxicity.
This is not the first time Sica has had legal problems. In 1999, Allstate Insurance Company filed two suits against 258 individuals suspected of participating in staged accident rings in Camden and Perth Amboy, New Jersey. A third suit targeted chiropractors, medical doctors, and related medical and business corporations who allegedly created a dummy medical corporation to misrepresent a chiropractic facility as a physician-owned medical center.
In addition to chelation therapy, Sica offers other questionable services, the most notable of which is "electrodermal screening" with the Listen System, which Sica says can "help identify patterns of environmental sensitivities."
Wisconsin Medical Examining Board
v.
Eleazar Kadile, MD
After years of serious questions about the medical practices of Eleazar Kadile, the Wisconsin Medical Examining Board has finally won its case against him. On November 21, 2003, he signed a stipulation and agreed to be disciplined, and have his license limited. So, despite the rants of Tim Bolen and others, the game is up.
Dr. Kadile agrees not to claim in any legal or administrative proceeding that the discipline imposed was not justified by the Findings of Fact stated.
According to public records, Dr. Kadile has engaged in the treatment of several patients in a manner that raised one or more of the following concerns:
the patient records appeared to be inadequate relative to legibility, history, physical exam, patient complaints and actions taken relative thereto, existing medical conditions, diagnostic testing, recommended treatment, informed consent, communication with other medical providers, diagnosis and management of medical conditions, and the accuracy of correspondence sent to third party payers regarding EDTA chelation therapy.
The Board concludes that the conduct described above violated one or more of the following: § Med 10.02(2)(o) and (w), Wis. Adm. Code, and §448.02(3)(c) Wis. Stats.
Eleazar M. Kadile, MD, is REPRIMANDED for his violations of § Med 10.02(2)(o) and (w), Wis. Adm. Code, in this matter.
IT IS FURTHER ORDERED, that the license to practice medicine and surgery of respondent is LIMITED as provided in §448.02(3)(e), Wis. Stats., and as follows:
1.. Respondent shall provide all patients with the attached "Notice to Patients" before commencing any treatment or therapy, and shall retain a copy in the chart.
2.. Respondent shall not engage or participate in any research on human subjects without the specific consent of the Board, which consent shall not be unreasonably withheld.
3.. Respondent shall not prescribe, dispense, or administer any prescription drug which is not FDA approved, or legally compounded using only ingredients which can be legally obtained for the purpose of medical treatment.
4.. Respondent may offer chelation therapy only if the patient signs the form which is attached to this Order
5.. All testing shall be performed by a CLIA regulated laboratory which is authorized to do the test performed.
6.. Respondent shall make no statement concerning a patient's condition, orally or in writing, to any third party payor or a patient (or patient's caregiver) which is not clearly supportable by the patient's health care record. Respondent shall not make any statement to a third party payor or a patient (or patient's caregiver) that a patient has abnormal levels of any substance without enclosing the laboratory report which supports that statement.
7.. Respondent shall not use any advertising which is false, misleading, or deceptive, including but not limited to the conduct described in pars. 2-4, of the Findings of Fact, above.
IT IS FURTHER ORDERED, that respondent's license is LIMITED in the following respect: respondent shall forthwith undergo an assessment to evaluate respondent's current abilities to practice medicine at his current practice, with his current patient population, and given the Stipulation and Order and facts of this case. Respondent may propose members of the assessment panel, but the selection of assessors is entirely within the discretion of the Program. The assessment shall include medical recordkeeping and be performed under the direction of the University of Wisconsin Continuing Medical Education Program (UW-CME) or another provider acceptable to the Board, and may include a cognitive screening assessment, peer interview, and/or physical examination. Respondent shall have completed all portions of the assessment process for which he is responsible (including payment of all required fees), as requested by UW-CME, on a schedule as established by UW-CME, but no later than 90 days after the date of this Order, unless the Board grants an extension at the request of UW-CME.
If the results of this assessment process shows a material deficiency in respondent's abilities, respondent shall participate in and successfully complete an educational program established through the UW-CME based upon on the results of the assessment. Respondent shall complete this program within the time parameters established by the UW-CME, but no later than two years from the date of this Order.
Respondent shall be responsible for all costs incurred for the assessment and educational program under the terms of this Order, and shall timely pay all fees when due.
The UW-CME shall certify to the Board the results of the assessment and educational program upon the completion of the assessment and upon the completion of the educational program. Upon receipt of certification of completion of the terms and conditions set forth above, the Medical Examining Board shall inform respondent that his obligations under this portion of this order have been satisfied, and that his license is no longer limited in this respect.
Upon completion of the UW-CME assessment and, if applicable, the subsequent educational program as described in this section, respondent shall, at his own expense, retain a physician who is board certified in a specialty recognized by the American Board of Medical Specialties, who is acceptable to the Board, such acceptance not to be unreasonably withheld. The retained physician shall, on behalf of the Board, review a sampling of respondent's patient charts generated after the date of this Order as the retained physician shall determine, no less often than every three months, or as the retained physician shall determine is necessary to timely review the records, and shall report to the Board any conduct which may be in violation of this Order. The retained physician's sole duty is to the Board and not to any patient or third party. Respondent shall cooperate at all times with the retained physician including by timely paying any fees in full, answering questions, and providing supplemental information promptly when requested.
The chart review described herein shall terminate after two years of reviews, unless the Board extends it for cause.
If applicable, should respondent not successfully complete the educational program, this matter shall be referred to the Board to determine any other appropriate action relative to the conduct set out in the Findings of Fact, which may include any action permitted by §448.02(3)(c), Wis. Stats. Respondent and the Division will have the opportunity to present argument to the Board on that issue. The Board and respondent will receive the results of the assessment and respondent's status relative to completing the educational program, as evidence in determining appropriate action, if any.
IT IS FURTHER ORDERED, that whether respondent shall pay the costs of investigating and prosecuting this matter shall be determined by the Board in a separate order.
IT IS FURTHER ORDERED. If the Board determines that there is probable cause to believe that respondent has violated any term of this Final Decision and Order, that finding of probable cause following an opportunity to be heard shall be deemed legally sufficient for action under §448.02(4), Wis. Stats.
Links to the case:
Evidence against chelation
- Critical appraisal of chelation therapy - Canadian Family Physician magazine - March 2003
Double-blind, randomized controlled trial in an outpatient setting. For patients with stable ischemic heart disease, does chelation therapy using ethylenediaminetetraacetic acid (EDTA) have a favourable effect on the ischemic threshold during exercise and improve patients’ quality of life?
- Chelation therapy for atherosclerotic cardiovascular disease - Cochrane review
At present, there is insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes of patients with atherosclerotic cardiovascular disease.
- Chelation therapy for ischemic heart disease: - Calgary study shows no benefit
CONCLUSION: Based on exercise time to ischemia, exercise capacity, and quality of life measurements, there is no evidence to support a beneficial effect of chelation therapy in patients with ischemic heart disease, stable angina, and a positive treadmill test for ischemia.
- Calgary study nixes chelation - March 21, 2001
American College of Cardiology meeting
Study: chelation therapy useless against heart disease - Treating the bloodstream with chelation therapy fails to relieve heart disease, say researchers from the University of Calgary in the first careful test of this widely used form of alternative medicine.
- Chelation therapy for coronary heart disease: An overview of all clinical investigations.
Am Heart J 2000 Jul;140(1):139-41
Ernst E
BACKGROUND: Chelation therapy is popular in the United States.
The question of whether it does more good than harm remains
controversial. AIM: The aim of this systematic review was to
summarize all the clinical evidence for or against the
effectiveness and efficacy of chelation therapy for coronary
heart disease. METHODS: A thorough search strategy was
implemented to retrieve all clinical investigations regardless
of whether they were controlled or uncontrolled. RESULTS: The
most striking finding is the almost total lack of convincing
evidence for efficacy. Numerous case reports and case series
were found. The majority of these publications seem to indicate
that chelation therapy is effective. Only 2 controlled clinical
trials were located. They provide no evidence that chelation
therapy is efficacious beyond a powerful placebo effect.
CONCLUSION: Given the potential of chelation therapy to cause
severe adverse effects, this treatment should now be considered
obsolete.
- CPSO FAQ on chelation therapy opens the door to quacks -
In recent years, the College of Physicians and Surgeons, feeling the mounting pressure by complementary medical practitioners, drafted guidelines for alternative medicine and chelation therapy along with other unproved methods. This has opened the door to dozens of unqualified GPs and even a psychiatrist to actively promote and practice chelation therapy.
- American College of Cardiology Position Statement
There is insufficient scientific evidence to justify the application of chelation therapy for
atherosclerosis on a clinical basis. At the present time, therefore, chelation therapy for
atherosclerosis should be applied only under an investigation protocol.
- Saul Green - Quackwatch Chelation therapy is a series of intravenous infusions containing a
sythetic amino acid (EDTA) and various other substances. It is
approved and effective for hypercalcemia and poisoning by heavy
metals such as lead. However, proponents falsely claim it is also
effective against atherosclerosis and is a valid alternative to established
medical interventions such as coronary bypass surgery. They also
claim it neutralizes free radicals and eliminates dangerous metals from
the body. These claims are false.
The problem of free radicals damage is worsened when chelation
therapists add Vitamin C to the EDTA infusion mixture. Based on numerous reviews of the world's medical literature, the
FDA, National Institutes of Health,National Research Council,
California Medical Society, American Medical Association, Centers
for Disease Control and Prevention, American Heart Association,
American College of Physicians, American Academy of Family
Practice, American Society for Clinical Pharmacology Therapeutics,
American College of Cardiology, and American Osteopathic
Association have concluded that chelation doesn't work.
It is also not risk free -- cases of fatal renal damage and other
complications have been reported. Prolonged chelation will deplete
serum mineral content. In the absence of demonstrated efficacy,
assuming such risks is not justified.
One must also consider the significant risks inherent in choosing to
forego needed medical treatment in order to pursue an alternative with
no therapeutic value.
- American Heart Association position on chelation
The American Heart Association has reviewed the available literature on the use of chelation
(E.D.T.A., ethylenediamine tetraacetic acid) in treating arteriosclerotic heart disease. They found
no scientific evidence to demonstrate any benefit from this form of therapy.
- Getting to the Heart of the Matter - A closer look at chelation therapy - The Mayo Clinic - The Mayo Clinic had previously had a full article on line, but for some reason they've pulled it. We've asked them why. "While the risks from
chelation therapy are low, there is still no scientific
proof of any benefits to cardiac health. And, while
chelation is less expensive than other options, it's not
cheap. Costs run in the thousands of dollars and
typically are not covered by insurance, including
Medicare," according to Dr. Gertz.
- Medical quackery alive and well - The Mayo Clinic had previously had a full article on line, but for some reason they've pulled it. We've asked them why.
Medical quackery can threaten both your health and
pocketbook. Snake oil salesmen used to tout cures
from the back of a horse-drawn wagon; now they use
the Internet and sophisticated marketing ploys. But it's
still the same: Use people's fears to "make a killing"
— sometimes literally — selling worthless medical
treatments. Learn how you can avoid falling prey.
Quackery thrives on vulnerability. In some areas of life,
we are all vulnerable. You may be so anxious that
hope overwhelms reason. Or you may be simply
unsuspecting and be enticed by catchy advertising
and convincing personal testimonials.
- Review: Chelation therapy is ineffective for peripheral arterial occlusive disease - ACP Journal Club, March/April 1998.
Intravenous chelation therapy offers no benefit to patients with
peripheral arterial occlusive disease. 3 trials found no
intergroup differences for patients who received EDTA
compared with those who received placebo, and a subgroup
analysis from 1 of the trials reported a trend toward greater
improvements for patients who received placebo than for
those who received EDTA.
- Chelation therapy in the rats shows potential harm - CMAJ - April 2000
Conclusions: Chelation therapy using intravenous EDTA has no beneficial
effects on the arterial lesions in the atherosclerotic JCR:LA-cp rat. The
increase in plasma triglyceride concentrations would be grounds for
concern in human patients.
- Why Aetna won't cover it
- CIGNAMEDICARE won't pay
Controversy
- Canadian MDs remain sceptical as chelation therapy goes mainstream in Saskatchewan
Murray Oliver - CMAJ 1997;157:750-3
The College of Physicians and Surgeons of Saskatchewan recently agreed to allow physicians to
administer chelation therapy. Supporters, relying on anecdotal evidence, say it works wonders in
overcoming heart disease, but many physicians remain profoundly sceptical. In Saskatchewan, the
college decision has proved popular with patients but has drawn an angry reaction from doctors.
- Freedom of Choice in Health Care - Fraser Institute Forum Cynthia Ramsay
How can provincial medical licensing bodies refuse to acknowledge the benefits of alternative treatments such as chelation
therapy on the grounds that they have not been subjected to double-blind tests (or that such tests performed to date have
resulted in indeterminate conclusions) while "accepted" practices such as angioplasties and bypass surgery have not undergone
such examinations? [Practitioners of chelation therapy are not advocating it as a replacement to surgery but as an option before
resorting to surgery, or after surgery has failed. They have asked the colleges to conduct studies but have been refused. As
well, with E.D.T.A. being a generic substance, it is not profitable for pharmaceutical companies to conduct extensive testing
of chelation therapy.
As it stands, there have been more than 3,000 research and clinical papers published on chelation therapy in North America
alone and, over the last 20 years, over 1 million people have received chelation therapy worldwide. In the United States, the
American College of Advancement in Medicine trains and certifies doctors who wish to practise chelation therapy and it
provides guidelines for the safe use of chelation treatment.] Table 1 should indicate why some patients are choosing chelation
therapy, even though it is condemned by almost all of the medical licensing bodies in Canada, it is not covered by any
provincial health insurance plan, and there is not a lot of rigorously scientific evidence that it actually works (or whether the
beneficial results that have been reported are produced by a placebo effect).
(Ed. This 1995 foray by the ultra-conservative Fraser Institute shows that there are people who believe that the earth is still flat. I don't know how the FI would rethink this position today after the FTC bashed ACAM's claims.)
Chelation abuse
Search Google News for chelation therapy
Scott Rulon Werner indicted in Utah - A 46 year old Southern Utah medical doctor faces the music with elaborate scheme to defraud insurance companies. He billed false claims for 56 patients. What's even more interesting is that the Utah Division of Occupational and Professional Licensing had no current contact information for him.
He had been previously been disciplined by the DOPL back in 1996.
My guess is that the Utah insurance companies will be the only way that these bogus procedures will be stopped. The Utah DOPL fancies itself as a defender of the rights of their doctors, including naturopaths to run any scam that they want, as long as patients are informed. But, the bottom line is basically this. It doesn't work, no insurance company should pay for it, and the DOPL is wrong in not prosecuting these quacks.
Controversial therapy lures problem doctors to Florida
Dr. Cristino Enriquez's medical career had hit the skids.
He'd served seven months of an 18-month prison sentence
for Medicare fraud, and state officials were threatening to
revoke his license.
Enriquez begged forgiveness in a 1991 letter to Florida's
Board of Medicine. He promised to devote his life to
ministering to the poor -- and never again to open a private
medical practice.
The state let the doctor keep his license.
Today, Enriquez practices anti-aging medicine at offices in
Plantation and Miami, where he mixes chelation therapy with
Christian biblical teachings and prayer.
The Sun-Sentinel documented that 42, or about 28
percent, of 146 Florida doctors who offer chelation therapy
in their offices have been sanctioned by the state's medical
or osteopathic licensing boards, most in the past decade.
Offenses range from shoddy medical care to reckless
dispensation of narcotics, state records show.
Even chelation boosters acknowledge that chelation
cannot hope to brush up its reputation without tighter
standards to eliminate fringe doctors whose activities give
the industry a bad name, and to rid it of those who make
exaggerated claims for success.
Another feud has erupted because chiropractors are
opening chelation centers and hiring physicians to supervise
the treatments. Some centers are charging as little as $35 a
session, about a third of what most chelation doctors
charge.
"Chiropractors are using an M.D. who's a front for them,"
said Ahner, who has administered chelation treatments for
the past 18 years.
"Some hire an M.D. who has nothing to do, pay him
whatever, and he signs off," said Ahner, himself a former
chiropractor who is now a medical doctor.
Ahner said he also worries that too many doctors not
properly trained are landing in the field.
California Medical Board Tackles Chelation Therapy Abuse
The Health Quality Enforcement Section of the California Attorney General's (AG) Office contends that it prosecutes three or four cases a year involving the use of EDTA chelation therapy (CT) to treat patients for a variety of ailments other than those for which the procedure is approved (ie, "off-label use"). The AG's office states that they always win such cases, but that these cases are expensive to prosecute and require the same battle of expert opinion over and over again. The AG noted that CT is not harmful to patients at the doses usually used, but emphasized that paying for useless therapy is economically harmful, and may cause indirect harm if patients fail to seek effective therapy in lieu of CT. The AG's office asked the Medical Board of California MBC to consider asking for statutory restrictions that would make the off-label use of CT illegal without an FDA Investigative New Drug license. On Feb 4, the MBC debated the merits of creating such a law. Physicians John Renner and Wallace Sampson provided evidence that CT is used to treat more than 84 conditions for which there is no scientific evidence of effectiveness. The California Medical Association submitted a Medical Practice Opinion stating that it is appropriate to limit CT to heavy metal poisoning, hyper-calcemia, digitalis toxicity, and corneal calcium deposits, or as part of a controlled clinical trial under FDA standards.
Representatives of the American College for Advancement in Medicine, a national organization established primarily to support the off-label use of CT, argued that the procedure was useful, particularly in the treatment of circulatory problems. Julian Whitaker, MD, a highly vocal advocate of CT, claims that the
dispute is economic. He says that by diverting 100 patients a year from coronary by-pass surgery he prevents Orange County hospitals from taking in $9 million. He charges $3,000 for 30 treatments. Dozens of patients gave impassioned personal testimonials claiming remarkable improvements or cures due to CT. After a heated debate, the MBC failed to pass a ban on off-label use except for treatment of heart disease of CT by a 9 to 9 vote. A total ban on the off-label use of CT failed by a vote of 6 to 12. A substantial majority agreed to the concept of regulating CT but failing to reach any agreement on specifics, postponed consideration of regulatory language until its next meeting. Observers said that the tense atmosphere did not lend itself to rational decision-making.
CHELATION DOCTOR TO PAY $2.15 MILLION IN DAMAGES
Houston, Texas physician Mohammed Kakvan was found grossly negligent in the 1992 death of Frank Vecchio, 61, owner of Del Vecchio Foods distribution company. Kakvan treated Vecchio's heart disease with ineffective chelation therapy. Chelation therapy for vascular disease has been condemned by the National Institutes of Health and every scientific medical organization that has reviewed it. [Physician Financial News, February, 1996, p.3]
ADMINISTRATIVE LAW JUDGE REVOKES HUGGINS' LICENSE
A 71-page report by Administrative Law Judge Nancy Connick provides substantive
information on the bogus theories and practices of maverick dentist Hal Huggins, and reveal the harm visited on 8 patients representative of Huggins' treatment protocol. The report reads like a primer on dental quackery. Huggins based his theories on strong personal belief, not on scientific evidence. MS patients formed a substantial portion of his patients. The report say that by 1980, he had treated over 400 MS patients. He blatantly lied, telling some patients he had cured himself of MS when he had never had the disease. Huggins charged each patient $6,000 for his program, plus the cost of the actual dentistry. He treated about 250 patients per year. Huggins also lied when he claimed to have thousands of publications in his library which supported his ideas. He also lied about having done studies himself on the effects of dental amalgam upon health. The report includes critical analyses of studies upon which he relies that purport to show that dental amalgams are unsafe. Huggins also made false representations that root canal therapy was dangerous, which is based upon the dubious writings of George Meinig, DDS, who relied upon the flawed work of Weston Price, DDS, done in the 1920s. Other specious practices included bogus diagnostic procedures and both worthless and hazardous treatment procedures. Huggins did inappropriate procedures such as administering EDTA chelation therapy to remove mercury from the body. EDTA binds lead, not mercury, making it useless. His addition of vitamin C to the intravenous solution increased the hazard of the infusion to the kidneys. The reports of what happened to 8 patients are stories of human tragedies.
Huggins often videoed patients during periods when they were optimistic, using them as testimonials to prove the value of his methods. Reading the details of patient abuse helps put the harm done by quackery into focus. Connock concluded that "Given his steadfast and longstanding commitment to his theories in the face of substantial reasoned evidence to the contrary, it is evident that nothing will stop (him) from practicing the treatments he has developed short of
revocation of his license to practice dentistry" which she did on Feb 29. State law allows a one-month period for exceptions to be filed before the Board of Dental Examiners can act on the judge's decision. That period ended on March 29. The board will take up the case at its May 1 meeting. No exceptions had been filed at the time we inquired March 28.
Oral Chelation Scam thrives in Canada
Chelation at the CKNX Corral
AM Radio-920 of rural Wingham, Ontario, invited Florida based salesman to market bogus pills and syrups made from bee pollen, royal jelly, and a few other things. Why was the DJ so upset when we filed a complaint with the Canadian Broadcast Standards Council? Why, he was only trying to improve the local economy. Damn it, and I thought that CNN was trying to improve our local economy during the Walkerton E. Coli tragedy
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